We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

CD133+ Autologous Cells After Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400959
First Posted: November 17, 2006
Last Update Posted: November 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  Purpose

TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.

TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).

OBJECTIVES Primary:

  1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
  2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.

    Secondary:

  3. To evaluate the disease-related morbility of the target population.

Condition Intervention Phase
Acute Myocardial Infarction Procedure: cd133+cell intracoronary administration Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
  • Ejection fraction (%) evaluated by 2D echocardiography;

Secondary Outcome Measures:
  • perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
  • Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D

Estimated Enrollment: 15
Study Start Date: June 2004
Estimated Study Completion Date: October 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent;
  • age: 18-65 years;
  • large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
  • signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van’t Hof et al., Circulation, 1998); life expectancy more than 6 months.

Exclusion Criteria:

  • Pregnancy;
  • indication to aorto-coronaric by-pass;
  • neoplasia (previous or in progress);
  • primary diseases of the BM;
  • diabetes;
  • immunosuppressive therapy;
  • laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
  • severe co-morbidity.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400959


Locations
Italy
Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan, Italy
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Rosaria Giordano, MD Cell Factory Department of Regenerative Medicine Policlinic Milan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00400959     History of Changes
Other Study ID Numbers: CFT92002
First Submitted: November 14, 2006
First Posted: November 17, 2006
Last Update Posted: November 17, 2006
Last Verified: November 2006

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
cell therapy
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases